HEARTLINE NEEDLE HOLDER

GUDID B0992800035L0

HEARTLINE NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE DUST CURVED JAW SQUEEZE HANDLE

SONTEC INSTRUMENTS, INC.

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• Primary Device ID: B0992800035L0
• NIH Device Record Key: cf37c1bc-c559-4fe9-883e-993cdaecb405
• Commercial Distribution Discontinuation: 2018-06-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: HEARTLINE NEEDLE HOLDER
• Version Model Number: 2800-035L
• Company DUNS: 040729840
• Company Name: SONTEC INSTRUMENTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com

Device Dimensions

• Length: 28.7 Centimeter
• Device Size Text, specify: 0
• Length: 28.7 Centimeter
• Device Size Text, specify: 0
• Length: 28.7 Centimeter
• Device Size Text, specify: 0
• Length: 28.7 Centimeter
• Device Size Text, specify: 0
• Length: 28.7 Centimeter
• Device Size Text, specify: 0
• Length: 28.7 Centimeter
• Device Size Text, specify: 0
• Length: 28.7 Centimeter
• Device Size Text, specify: 0
• Length: 28.7 Centimeter
• Device Size Text, specify: 0
• Length: 28.7 Centimeter
• Device Size Text, specify: 0
• Length: 28.7 Centimeter
• Device Size Text, specify: 0
• Length: 28.7 Centimeter
• Device Size Text, specify: 0
• Length: 28.7 Centimeter
• Device Size Text, specify: 0
• Length: 28.7 Centimeter
• Device Size Text, specify: 0
• Length: 28.7 Centimeter
• Device Size Text, specify: 0
• Length: 28.7 Centimeter
• Device Size Text, specify: 0
• Length: 28.7 Centimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B0992800035L0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152400

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[B0992800035L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800035L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800035L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800035L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800035L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800035L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800035L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800035L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800035L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800035L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800035L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800035L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800035L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800035L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800035L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800035L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 8
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-19

On-Brand Devices [HEARTLINE NEEDLE HOLDER]

• B0992800035S0: HEARTLINE NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE DUST CURVED JAW SQUEEZE HANDLE
• B09928000350: HEARTLINE NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE DUST CURVED JAW SQUEEZE HANDLE
• B0992800030S0: HEARTLINE NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE DUST STRAIGHT JAW SQUEEZE HANDLE
• B0992800035L0: HEARTLINE NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE DUST CURVED JAW SQUEEZE HANDLE
• B0992800030L0: HEARTLINE NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE DUST STRAIGHT JAW SQUEEZE HANDLE
• 00192896110496: Heartline Needle Holder With Lock 1, 2 X 8, 5 Millimeter Tungsten Carbide Dust Jaw Curved Squeez